Preparing for ISO 9001:2015
Shannon Wetzel, Managing Editor
Click here to see this story as it appears in the November 2017 issue of Modern Casting
The ultimate deadline for all facilities holding an ISO 9001:2008 certification to transition to the updated ISO 9001:2015 standard is approaching in 2018. Because the ISO 9001:2008 certification lasts for three years before the need to recertify, facilities that received their certification as late as September 23, 2015 only have until September 15, 2018 to transition to the new standard without a lapse.
Why did ISO update the standard?
The new standard was updated for multiple reasons. ISO standards are reviewed every five years and revised if needed at that time. The International Standard Organization (ISO) cited increased globalization, increased customer expectations and more access to information as changes that needed to be reflected in a revised standard.
ISO also wanted to restructure the standard to be aligned better with other ISO management system standards to simplify certification for companies using multiple management systems.
What is different about the new standard?
Where previously the application was organized around eight elements, the new standard has 10 elements, but most of the content within the elements are the same.
“They are the same basic elements, with some items moved around,” said Ron Spencer, a quality manager at AFS Corporate Member Rochester Metal Products Corp. (Rochester, Indiana) who is helping lead the transition to the new standard at the iron casting facility. “The focus is to use risk-based thinking. So ISO took away the term ‘preventative actions’ and uses language that encourages organizations to think about the risk in everything they do.”
The chart in Figure 1 shows the basic flow of quality management actions outlined in the ISO 9001:2015 standard through the plan-do-check-act model. Part of the planning function is to perform an analysis of the organization to identify potential risks to the business.
“You are looking at what are the internal and external factors that affect how your business operates to an optimum level.” Spencer said.
External factors can include technology advances, exchange rate, competition, the market, oil prices, legislation, vendors and the labor market. Internal factors can include worker competency, turnover rate, complexity of your processes, customer requirements, and the age of your equipment. The chart in Figure 2 gives an example of how to assign a numerical value to the various risks your organization faces.
“As part of the standard, you have to be able to describe your organization and where you fit in the world and have plans for addressing the internal and external issues,” Spencer said. “What they want you to do is, for example, analyze what your competition is doing or what affects your prices, like energy costs. In the chart you assign a value to the probability for it to occur, what kind of impact it would have, and how easily you will detect whether this risk is occurring. You multiply the number for the prioritizer to determine where to place your resources in avoiding risks.”
When completing this exercise, organizations should focus only on the issues that can affect customer satisfaction and delivery of a quality product or service.
“An auditor wants to see you have analyzed the external and internal factors that affect your business and are making plans to move forward,” Spencer said. “It helps show the leadership has vision.”
After planning for risks, the company must supply the support and resources to guard against them. The standard calls for documentation through the various pieces of an organization’s processes to identify trends and act upon the information collected and dispersed to the appropriate people.
“The new standard doesn’t include a procedure for the document control (as it did before), but it does say you have to have the needed documentation to properly run your organization,” Spencer said.
Documentation is one of the things an ISO auditor will examine when it inspects your facility’s application.
If I have an ISO 9001:2008 standard, how do I transition to the new one?
ISO offers the following six tips for organizations transition from the 2008 version to the 2015 version:
Become familiar with the new document. Some things have changed, but some remain the same.
Identify organizational gaps that will need to be addressed to meet the new requirements.
Develop an implementation plan.
Provide appropriate training and awareness to staff, vendors and subcontractors.
Update the existing quality management system to meet the revised requirements.
Talk to a certification body about transitioning to the new version.
My organization does not hold an ISO certification. What are the benefits of getting one?
For many metalcasting facilities, the implementation of a quality management system through ISO certification is ignited by customer request or preference. Holding a certification can signal to customers that a foundry is committed to continuous improvement and has invested the time and resources to analyze, plan, implement and make adjustments as needed. A quality management system, like the one outlined in the ISO standard, is a tool to produce quality castings in a consistent manner.